Compositions and methods
Disclosed herein are therapeutic compositions containing non-pathogenic, germination-competent bacterial spores, for the prevention, control, and treatment of gastrointestinal diseases, disorders and conditions and for general nutritional health.
1. A therapeutic composition formulated for oral administration comprising a purified population of bacteria, an enteric coating, and a capsule, wherein the purified population of bacteria consist of spore-forming bacteria, and wherein at least one of the spore-forming bacteria are selected from the group consisting of Clostridium methylpentosum, Clostridium sp YIT 12069 , Anaerofustis stercorihominis, Bacteroides galacturonicus, Bacteroides pectinophilus, Brachyspira pilosicoli, Clostridium beijerinckii, Clostridium carnis, Clostridium favososporum, Clostridium sp. L2-50, Clostridium sp. MT4 E, Clostridium sp. NML 04A032 , Clostridium sp. SS211 , Clostridium stercorarium, Clostridium xylanolyticum, Coprococcus sp. ART55/1 , Deferribacteres sp. oral clone JV006 , Desuljitobacterium frappieri, Exiguobacterium acetylicum, Lachnospira multipara , and Lachnospira pectinoschiza.
2. The composition of claim 1 , wherein the spore-forming bacteria consists essentially of germinable bacterial spores.
3. The composition of claim 1 , wherein the composition is derived from a fecal material subjected to ethanol treatment or heat treatment.
4. The composition of claim 3 , wherein the composition is derived from fecal material subjected to ethanol treatment.
5. The composition of claim 4 , wherein the composition is derived from fecal material subjected to treatment with 30-90% ethanol.
6. The composition of claim 4 , wherein the composition is derived from fecal material subjected to treatment with 50-70% ethanol.
7. The composition of claim 4 , wherein the composition is derived from fecal material subjected to treatment with 50% ethanol.
8. The composition of claim 4 , wherein the composition augments a titer of one or more non-pathogenic Bacteroides selected from the group consisting of Bacteroides sp. 4_1_36 , Bacteroides cellulosilyticus, Bacteroides sp. 1_1_30 , Bacteroides uniformis, Bacteroides ovatus, Bacteroides dorei, Bacteroides xylanisolvens , and Bacteroides sp. 3_1_19; and
wherein the non-pathogenic Bacteroides titer is augmented in the gastrointestinal tract of the subject.
9. The composition of claim 3 , wherein the fecal material is a 10 to 20% fecal suspension.
10. The composition of claim 3 , wherein the fecal material is obtained from a validated mammalian donor subject not having a detectable level of a pathogen or a pathobiont prior to production of the fecal material.
11. The composition of claim 3 , wherein the fecal material is obtained from a validated mammalian donor subject not having a detectable level of a blood-borne pathogen or a fecal bacterial pathogen prior to production of the fecal material.
12. The composition of claim 1 , wherein the composition comprises at least 10×10 4 colony forming units of the spore-forming bacteria per dose of the composition.
13. The composition of claim 1 , wherein the capsule is a delayed release capsule.
14. The composition of claim 1 , wherein the purified population of bacteria are substantially free of residual habitat products.
15. The composition of claim 14 , wherein the residual habitat product is an abiotic material, a human or animal cell, a virus, a fungus, a mycoplasma , a toxoplasma , an eukaryotic parasite, or a combination thereof.
16. The composition of claim 1 , wherein the composition further comprises an excipient.
17. The composition of claim 16 , wherein the excipient is a germinant.
18. The composition of claim 1 , wherein the purified population of bacteria are lyophilized.